The Effect of Platelet Rich Fibrin Layers on Peri-implant Tissue Phenotype

Al-Mustansiriyah University

Status: Completed

Conditions: Platelet Rich Fibrin; Keratinized Mucosa; Dental Implant; Crestal Bone Loss

Treatments: Procedure: Dental implant placement without PRF; Biological: Triple-layer PRF membrane application; Biological: Single-layer PRF membrane application

Study type: Interventional

Funder types: Other

Identifiers

NCT07033351

MUOSU-202131

Details and patient eligibility

About

The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period.

Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all?

To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts.

Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.

Enrollment: 31 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults (male or female) over 18 years of age.
• Partially edentulous spaces.
• No history of bone augmentation procedures in the implant site.
• Good oral health, as measured by:
• Calibrated gingival bleeding index (≤10%)
• O'Leary plaque index (<10%)

Exclusion criteria

• Bleeding disorders.
• Compromised immune systems.
• Excessive smoking or alcohol consumption.
• Poor oral hygiene.
• Diabetes.
• Inability to attend follow-up visits.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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31 participants in 3 patient groups

0 PRF

Active Comparator group

Description:

Each implant placed in this group did NOT have PRF membrane placed over the implant.

Treatment:

Procedure: Dental implant placement without PRF

1 PRF

Experimental group

Description:

Each implant placed in this group had ONE PRF membrane placed over the implant.

Treatment:

Biological: Single-layer PRF membrane application

3 PRF

Experimental group

Description:

Each implant placed in this group had THTEE STACKED PRF membranes placed over the implant.

Treatment:

Biological: Triple-layer PRF membrane application